Metoprolol biofarm zk

Package leaflet: Information for the patient

Metoprolol Biofarm ZK, 47.5 mg, prolonged-release tablets
Metoprololi succinas
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Metoprolol Biofarm ZK is and what it is used for
2. What you need to know before taking Metoprolol Biofarm ZK
3. How to take Metoprolol Biofarm ZK
4. Possible side effects
5. How to store Metoprolol Biofarm ZK
6. Contents of the pack and other information

1. What Metoprolol Biofarm ZK is and what it is used for

Metoprolol Biofarm ZK belongs to a group of medicines called beta-blockers.
It is used for the treatment of:

• high blood pressure
• severe chest pain caused by inadequate oxygen supply to the heart (angina pectoris)
• irregular heart rhythm (arrhythmia)
• stable heart failure with symptoms (such as breathlessness or swollen ankles), when other medicines are also used to treat heart failure
• palpitations (awareness of heartbeats) caused by functional disturbances of the heart.

It is used for the prevention of:

• recurrence of heart attack or heart damage after a heart attack
• migraine.

Children and adolescents aged 6 to 18 years
Treatment of high blood pressure (hypertension).

2. Important information before using Metoprolol Biofarm ZK

Do not use Metoprolol Biofarm ZK and inform your doctor if the patient:

• is allergic to metoprolol, other beta-blocking agents, or any of the other ingredients of this medicine (listed in section 6)
• has conduction disorders (second- or third-degree atrioventricular block) or heart rhythm disorders (sick sinus syndrome)
• has untreated heart failure, is receiving treatment with cardiac stimulants, or is in cardiogenic shock
• has severe circulatory disorders (severe peripheral circulatory disorders)
• has slow heart rate (less than 50 beats per minute)
• has low blood pressure
• has increased blood acidity (metabolic acidosis)
• has severe asthma or COPD (chronic obstructive pulmonary disease)
• has untreated pheochromocytoma (a rare tumour in one of the adrenal glands causing high blood pressure)
• has heart failure and systolic blood pressure below 100 mm Hg.

The following medicines are being used (see also “Metoprolol Biofarm ZK and other medicines”):

• monoamine oxidase inhibitors (MAOIs) (used in the treatment of depression)
• verapamil and diltiazem (used to reduce blood pressure)
• antiarrhythmic medicines such as disopyramide.

Exercise particular caution when using Metoprolol Biofarm ZK and inform your doctor if the patient:

• has asthma
• has Prinzmetal's angina (severe chest pain usually occurring at night)
• has diabetes (the medicine may mask symptoms of low blood sugar)
• has pheochromocytoma (a rare tumour in one of the adrenal glands causing high blood pressure)
• is being treated to reduce allergic reactions. Metoprolol Biofarm ZK may increase sensitivity to substances causing allergy in the patient or worsen the severity of allergic reactions.
• has hyperthyroidism (the medicine may mask symptoms such as rapid heartbeat, excessive sweating, tremor, anxiety, increased appetite, or weight loss)
• has or has had psoriasis (severe skin rash)
• has circulatory disorders causing tingling, paleness, or blueness of fingers and toes
• has heart conduction disorders (heart block)
• has heart failure and one of the following:
• unstable heart failure (NYHA class IV)
• myocardial infarction or angina attack within the last 28 days
• impaired kidney or liver function
• age under 40 or over 80 years
• heart valve disease
• thickening of the heart muscle
• heart surgery within the last 4 months.

If the patient is scheduled for surgery or a procedure under anaesthesia, inform the doctor or
dentist about the use of metoprolol tablets.
Metoprolol Biofarm ZK and other medicines
Do not take Metoprolol Biofarm ZK if the following medicines are being used simultaneously:

• monoamine oxidase inhibitors (MAOIs) used in the treatment of depression (may intensify the blood pressure-lowering effect)
• other blood pressure-lowering medicines such as verapamil and diltiazem (may cause slowing of the heartbeat and excessive reduction in blood pressure)
• antiarrhythmic medicines such as disopyramide (may increase the risk of irregular or slow heartbeat and reduced heart function).

Before taking Metoprolol Biofarm ZK, tell your doctor or pharmacist
about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
In particular, inform about the following medicines:

• The following medicines may intensify the blood pressure-lowering effect:
• cimetidine (used in peptic ulcer disease)
• hydralazine or clonidine (blood pressure-lowering medicines)
• terbinafine (used in fungal infections)
• paroxetine, fluoxetine, and sertraline (used in depression)
• hydroxychloroquine (used in the treatment of malaria)
• chlorpromazine, triflupromazine, chlorprothixene (antipsychotic medicines)
• amiodarone, quinidine, and propafenone (used in irregular heart rhythm)
• diphenhydramine (antihistamine)
• celecoxib (used in pain treatment).
• The following medicines may reduce the blood pressure-lowering effect:
• indomethacin (used in pain treatment)
• rifampicin (antibiotic).
• Other medicines may interfere with the action of metoprolol or their action may be affected by metoprolol:
• other beta-blocking agents, e.g. eye drops
• adrenaline (epinephrine), noradrenaline (norepinephrine), or other sympathomimetics
• medicines used in the treatment of diabetes (symptoms of low blood sugar may be masked)
• lidocaine
• reserpine, alpha-methyldopa, guanfacine, cardiac glycosides.

Metoprolol Biofarm ZK with food and drink
Alcohol may intensify the blood pressure-lowering effect of Metoprolol Biofarm ZK tablets.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Use of Metoprolol Biofarm ZK is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Metoprolol Biofarm ZK may cause fatigue or dizziness. Before driving a car or operating
machinery, ensure these effects do not occur, especially after changing medications or after
concomitant alcohol intake.

3. How to use Metoprolol Biofarm ZK

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The tablets should be taken in the morning, once daily, with a glass of water. The tablets should be swallowed whole or divided into two equal doses. Do not chew or crush before swallowing.
Typical doses are:

• High blood pressure: 47.5 mg of metoprolol succinate once daily. If necessary, this dose may be increased to 95–190 mg once daily.
• Chest pain (angina pectoris): 95–190 mg of metoprolol succinate once daily.
• Irregular heartbeat (arrhythmia): 95–190 mg of metoprolol succinate once daily.
• Prevention of recurrent heart attack or heart damage after heart attack: 190 mg of metoprolol succinate once daily.
• Heart palpitations related to heart disease: 95 mg of metoprolol succinate once daily. This dose may be increased, if necessary, to 190 mg once daily.
• Prevention of migraine: 95–190 mg of metoprolol succinate once daily.
• Patients with stable heart failure: Use as directed by the doctor.

Patients with impaired liver function:
In patients with severe liver function impairment, the doctor will adjust the dose. Always follow the doctor's instructions.
Children and adolescents:
High blood pressure: in children aged 6 years and older, the dose depends on the child's body weight.
The doctor will determine the appropriate dose for your child.
The usual starting dose is 0.5 mg/kg body weight, not exceeding 50 mg, given once daily as a tablet with strength closest to the calculated dose.
The doctor may increase the dose up to 2 mg/kg body weight, depending on the patient's response to treatment.
Studies on doses exceeding 200 mg once daily in children and adolescents have not been conducted.
The use of Metoprolol Biofarm ZK tablets is not recommended in children under 6 years of age.
Taking more Metoprolol Biofarm ZK than recommended
If you accidentally take more than the prescribed dose, seek immediate medical attention at the nearest hospital or contact your doctor or pharmacist. Symptoms of overdose include: excessively low blood pressure (fatigue and dizziness), slowed heart rate, irregular heartbeat, cardiac arrest, shortness of breath, deep unconsciousness, nausea, vomiting, and bluish discoloration of the skin.
Missing a dose of Metoprolol Biofarm ZK
If you miss a dose, take it as soon as possible and then continue according to your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Metoprolol Biofarm ZK treatment
Do not stop treatment with Metoprolol Biofarm ZK suddenly, as this may worsen symptoms of heart failure and increase the risk of heart attack. Dose adjustments or discontinuation of treatment should only be made after consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
You should stop taking the medicine and contact a doctor immediately if you experience an
allergic reaction, characterised by an itchy skin rash, facial flushing, swelling of the face, lips,
tongue or throat, difficulty breathing or swallowing. This is a very rare adverse effect. Immediate
treatment or hospitalisation may be necessary.
You should inform your doctor if you experience any of the following or any other adverse effects:

Very common (affects more than 1 in 10 people):

• fainting upon standing due to excessive lowering of blood pressure,
• fatigue.

Common (affects less than 1 in 10 but more than 1 in 100 people):

• slow heart rate,
• difficulty maintaining balance (very rarely with fainting),
• cold hands and feet,
• palpitations,
• dizziness, headache,
• nausea, diarrhoea, constipation, abdominal pain,
• shortness of breath associated with intense physical exertion.

Uncommon (affects less than 1 in 100 but more than 1 in 1,000 people):

• periodic worsening of heart failure symptoms,
• fluid retention in the body (oedema),
• chest pain,
• tingling and pricking sensations,
• muscle cramps,
• vomiting,
• weight gain,
• depression,
• reduced concentration,
• difficulty falling asleep (insomnia),
• drowsiness,
• nightmares,
• shortness of breath,
• rash,
• increased sweating.

Rare (affects less than 1 in 1,000 but more than 1 in 10,000 people):

• worsening of diabetes symptoms,
• nervousness, anxiety,
• visual disturbances,
• dryness or irritation of the eyes,
• conjunctivitis (eye disease),
• impotence (inability to achieve erection),
• Peyronie's disease (plastic hardening of the penis),
• irregular heartbeat,
• conduction disorders in the heart,
• dry mouth,
• catarrh,
• hair loss,
• changes in liver function tests.

Very rare (affects less than 1 in 10,000 people):

• changes in blood cell counts (thrombocytopenia, leukopenia),
• memory disturbances,
• disorientation,
• hallucinations,
• mood disturbances,
• tinnitus,
• hearing disturbances,
• taste disturbances,
• hepatitis,
• photosensitivity,
• worsening of psoriasis or development of psoriasis (skin disease),
• muscle weakness,
• joint pain,
• tissue necrosis in patients with severe circulatory disorders.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +48 22 49 21 301
Faks: +48 22 49 21 309
e-mail: [email protected]
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Metoprolol Biofarm ZK

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP):". The expiry date is also printed on the blister after "EXP:". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Metoprolol Biofarm ZK contains

• The active substance (the ingredient that makes the tablet work) is metoprolol succinate. Each tablet contains:
• 47.5 mg of metoprolol succinate, equivalent to 50 mg of metoprolol tartrate.
• The other ingredients are:
• tablet core: microcrystalline cellulose, methylcellulose, maize starch, glycerol, ethylcellulose and magnesium stearate;
• tablet coating: microcrystalline cellulose, hypromellose, stearic acid and titanium dioxide (E171).

What Metoprolol Biofarm ZK looks like and contents of the pack
Metoprolol Biofarm ZK 47.5 mg are white, oval, biconvex coated tablets, with a score line on both sides. The pack contains: 10, 14 or 28 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland

Manufacturer
Zakłady Farmaceutyczne Polpharma S.A.
Production Department in Nowa Dęba
ul. Szypowskiego 1,
39-460 Nowa Dęba,
Poland

For further information, please contact the local representative of the Marketing Authorisation Holder:
Poland
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
[email protected]
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